Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide

• Status: Suspended
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to determine whether metabolic control centers in the brain can be activated in patients with type 2 diabetes as compared to non-diabetic individuals. This is important since people with diabetes have inappropriately high production of glucose, which could be at least in part due to impaired activation of important brain centers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Diazoxide

Criteria

Inclusion Criteria:

• Type 2 Diabetes (T2D)

• Age: Between 21 and 70 y.o.

• BMI: <35

• A1c 8.0-12.0%

• Negative drug screen

• Not suffering from proliferative retinopathy, significant diabetic renal disease or severe neuropathy (including cardiovascular and gastrointestinal autonomic dysfunction)

• Healthy (ND)

• Age: Between 21 and 70 y.o.

• BMI: <30

• Negative drug screen

• No family history of diabetes among first-degree relatives (mother, father)

Exclusion Criteria:

• Age: Under 21 or over 70 y.o.

• BMI: >35 for T2D and >30 for ND

• Hypertension

• Severe polydipsia and polyuria

• Uncontrolled hyperlipidemia

• Clinically significant liver dysfunction

• Clinically significant kidney dysfunction

• Anemia

• Clinically significant leukocytosis or leukopenia

• Clinically significant thrombocytopenia or thrombocytosis

• Coagulopathy

• Positive urine drug screen

• Urinalysis: Clinically significant abnormalities

• Clinically significant electrolyte abnormalities

• Smoking >10 cig/day

• Alcohol: Men >14 drinks/wk or > 4 drinks/day, Women >7 drinks/wk or >3 drinks/day

• History of chronic liver disease, active hepatitis infection, HIV/AIDS, chronic kidney disease (stage 3 or greater), active cancer, cardiovascular disease or other heart disease, systemic rheumatologic conditions, seizures, bleeding disorders, muscle disease

• Surgeries that involve removal of endocrine glands except for thyroidectomy

• Pregnant women

• Subject enrolled in another study less than one month prior to the anticipated start date of the proposed study

• Family history: family history of premature cardiac death

• Allergies to medication administered during study

• Uncontrolled psychiatric disorders

• Perimenopausal women who are experiencing/have experienced hot flashes

• Any contraindications for MRI: presence of any non-MRI compatible implants including pacemaker, aneurysm clip, cochlear implant, neurostimulator; history of eye injury with metal; history of ever being a metal worker; history of gunshot wounds or any other imbedded metal objects; history of claustrophobia or prior episodes of significant anxiety or discomfort while obtaining an MRI.

• Any condition which in the opinion of the PI makes the subject ill-suited for participation in the study